Allergy Towards Grass and Bronchial Inflammation - Related to Immunotherapy and Exhaled Nitrogen Oxide

June 11, 2007 updated by: Bispebjerg Hospital

Does Specific Immunotherapy Possess Immunomodulative Effects at the Bronchial Mucosa Level Among Adults With Atopic Diseases?

The purpose of this study is to evaluate the immunomodulatory effect of treatment of allergic rhinitis symptoms with specific immunotherapy by measurement of pulmonary inflammatory markers, and among others, exhaled nitric oxide.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Thomas B Knudsen, Medical student
  • Phone Number: +45 61 70 96 99
  • Email: thomas@uknet.dk

Study Contact Backup

  • Name: Vibeke Backer, M.D., M.D.Sci
  • Phone Number: +45 35 31 30 69
  • Email: backer@dadlnet.dk

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400 NV
        • Recruiting
        • Bispebjerg Hospital
        • Contact:
          • Thomas B Knudsen, Medical student
          • Phone Number: +45 61 70 96 99
          • Email: thomas@uknet.dk
        • Sub-Investigator:
          • Thomas B Knudsen, Medical student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-45 years old
  • Skin prick test or RAS test and physical examination conclude that the patient will have a beneficial effect from specific immunotherapy

Exclusion Criteria:

  • Other diseases except atopic disease
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Spirometry
Skin prick test
Methacholine provocation of the pulmonary system
Exhaled nitric oxide
Immunoglobulin E (IgE) status
Sputum examination
Condensation of exhaled air

Secondary Outcome Measures

Outcome Measure
Questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Investigators

  • Principal Investigator: Vibeke Backer, M.D., M.D.Sci, Lungeforskningsenheden v/Bispebjerg hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

April 5, 2006

First Submitted That Met QC Criteria

April 5, 2006

First Posted (Estimate)

April 10, 2006

Study Record Updates

Last Update Posted (Estimate)

June 12, 2007

Last Update Submitted That Met QC Criteria

June 11, 2007

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SITNO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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